Medical dressings, systems, and methods employing sealants

ABSTRACT

According to an illustrative embodiment, a system for treating a wound at a tissue site of a patient comprising a reduced-pressure source to supply reduced pressure, a drape adhering to the tissue site to cover the wound where possible leak passages between the drape and the tissue site may occur, and a seal disposed between the drape and the tissue site, is disclosed. The seal is adapted to react with a fluid to form a sealant substantially filling the passages in response to air leaking through the passages from outside the drape when reduced pressure is applied to the wound. According to another illustrative embodiment, a method for sealing a drape to a tissue site for treating a wound at the tissue site comprising applying the drape to cover the tissue site whereby passages are formed between the drape and the tissue site, positioning a seal between the drape and the tissue site wherein the seal is adapted to react with a fluid to form a sealant for substantially filling the passages, is also disclosed.

RELATED APPLICATION

The present invention claims the benefit, under 35 USC §119(e), of thefiling of U.S. Provisional Patent Application Ser. No. 61/242,488,entitled “System and Method for Sealing a Wound,” filed Sep. 15, 2009,which is incorporated herein by reference for all purposes.

BACKGROUND

The present invention relates generally to medical treatment systems,and more particularly, medical dressings, systems, and methods employingsealants.

Clinical studies and practice have shown that providing a reducedpressure in proximity to a tissue site augments and accelerates thegrowth of new tissue at the tissue site. The applications of thisphenomenon are numerous, but application of reduced pressure has beenparticularly successful in treating wounds. This treatment (frequentlyreferred to in the medical community as “negative pressure woundtherapy,” “reduced pressure therapy,” or “vacuum therapy”) provides anumber of benefits, which may include faster healing and increasedformulation of granulation tissue. Unless otherwise indicated, as usedherein, “or” does not require mutual exclusivity.

SUMMARY

According to an illustrative embodiment, a system for treating a woundat a tissue site of a patient comprising a reduced-pressure source tosupply reduced pressure, a drape adhering to the tissue site to coverthe wound where possible leak passages between the drape and tissue sitemay occur, and a seal disposed between the drape and the tissue site, isdisclosed. The seal is adapted to react with a fluid to form a sealantsubstantially filling the passages in response to air leaking throughthe passages from outside the drape when reduced pressure is applied tothe wound.

According to another illustrative embodiment, an apparatus includes aseal having a first side and a second, tissue-facing side. The seal isadapted for placement adjacent the tissue site and is operable to expandin a presence of a fluid to form a substantially sealed space at thetissue site. The apparatus also includes a drape for covering thesealant and further forming the substantially sealed space.

According to another illustrative embodiment, a method for sealing adrape to a tissue site for treating a wound at the tissue sitecomprising applying the drape to cover the tissue site whereby passagesare formed between the drape and the tissue site, positioning a sealbetween the drape and the tissue site wherein the seal is adapted toreact with a fluid to form a sealant for substantially filling thepassages, is also disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic, cross-sectional view of a reduced-pressuretreatment system including dressing that utilizes a sealant according toone illustrative embodiment;

FIG. 2 is a schematic, plan view of the sealant and the wound shown inthe embodiment of FIG. 1;

FIG. 3 is a schematic, cross-sectional view of the dressing and thesealant shown in FIG. 1 after the sealant has transformed to agelatinous or liquid state;

FIG. 4 is a schematic, cross-sectional view of another embodiment ofdressing that utilizes a sealant in the reduced-pressure treatmentsystem of FIG. 1; and

FIG. 5 is a schematic, perspective view of a drape, sealant, and releaseliner for use with dressing of FIG. 4 according to one illustrativeembodiment.

DETAILED DESCRIPTION

In the following detailed description of the illustrative embodiments,reference is made to the accompanying drawings that form a part hereof.These embodiments are described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is understood thatother embodiments may be utilized and that logical structural,mechanical, electrical, and chemical changes may be made withoutdeparting from the spirit or scope of the invention. To avoid detail notnecessary to enable those skilled in the art to practice the embodimentsdescribed herein, the description may omit certain information known tothose skilled in the art. The following detailed description is,therefore, not to be taken in a limiting sense, and the scope of theillustrative embodiments are defined only by the appended claims.

The term “reduced pressure” as used herein generally refers to apressure less than the ambient pressure at a tissue site that is beingsubjected to treatment. In most cases, this reduced pressure will beless than the atmospheric pressure at which the patient is located.Alternatively, the reduced pressure may be less than a hydrostaticpressure associated with tissue at the tissue site. Although the terms“vacuum” and “negative pressure” may be used to describe the pressureapplied to the tissue site, the actual pressure reduction applied to thetissue site may be significantly less than the pressure reductionnormally associated with a complete vacuum. Reduced pressure mayinitially generate fluid flow in the area of the tissue site. As thehydrostatic pressure around the tissue site approaches the desiredreduced pressure, the flow may subside, and the reduced pressure is thenmaintained. Unless otherwise indicated, values of pressure stated hereinare gauge pressures. Similarly, references to increases in reducedpressure typically refer to a decrease in absolute pressure, whiledecreases in reduced pressure typically refer to an increase in absolutepressure.

The term “tissue site” as used herein includes, without limitation, awound or defect located on or within any tissue, including but notlimited to, bone tissue, adipose tissue, muscle tissue, neural tissue,dermal tissue, vascular tissue, connective tissue, cartilage, tendons,or ligaments. The term “tissue site” may further refer to areas of anytissue that are not necessarily wounded or defective, but are insteadareas in which it is desired to add or promote the growth of additionaltissue. For example, reduced pressure tissue treatment may be used incertain tissue areas to grow additional tissue that may be harvested andtransplanted to another tissue location. The tissue may be that of anymammal, such as a mouse, rat, rabbit, cat, dog, or primate, includinghumans, that are being treated as patients. Also, the wound at thetissue site may be due to a variety of causes, including trauma,surgery, degeneration, and other causes.

Referring to FIGS. 1 and 2, a reduced pressure treatment system 100 forapplying a reduced pressure to a tissue site 101 of a patient accordingto an illustrative embodiment where the tissue site 101 includes a wound102 surrounded by healthy tissue including, without limitation, anepidermis 103 of such tissue. The system 100 comprises a canister 104having a filter (not shown) contained within the canister 104 and afluid supply 106 for delivering a fluid 105 to the tissue site 101. Thecanister 104 is positioned in fluid communication with a reducedpressure source 108 and a reduced pressure dressing 110 that ispositioned at the tissue site 101. The reduced pressure dressing 110 isfluidly connected to the canister 104 by a conduit 112. The conduit 112may fluidly communicate with the reduced pressure dressing 110 through atubing adapter 114. A second conduit 116 fluidly connects the canister104 with the reduced pressure source 108.

The canister 104 may be a fluid reservoir, or collection member, tofilter or hold exudates and other fluids removed from the tissue site101. In one embodiment, the canister 104 and the reduced pressure source108 are integrated into a single housing structure. The fluid supply 106is fluidly connected to the reduced pressure dressing 110 by a thirdconduit 118 that may be connected directly to the reduced pressuredressing 110 (not shown) or indirectly via the conduit 112 whichrequires valves 122 and 124 for controlling the delivery of reducedpressure from the reduced pressure source 108 and/or the fluid 105 fromthe fluid supply 106, respectively. The fluid 105 may be any gas orliquid, and may contain growth factors, healing factors, or othersubstances to treat the wound 102 at the tissue site 101. For example,the fluid 105 may be air, water, saline, or dye saline.

In the embodiment illustrated in FIG. 1, the reduced pressure source 108is an electrically-driven vacuum pump. In another implementation, thereduced pressure source 108 may instead be a manually-actuated ormanually-charged pump that does not require electrical power. Thereduced pressure source 108 instead may be any other type of reducedpressure pump, or alternatively a wall suction port such as thoseavailable in hospitals and other medical facilities. The reducedpressure source 108 may be housed within or used in conjunction with areduced pressure treatment unit 128, which may also contain sensors,processing units, alarm indicators, memory, databases, software, displayunites, and user interfaces that further facilitate the application ofreduced pressure treatment to the tissue site 101. In one example, asensor or switch (not shown) may be disposed at or near the reducedpressure source 108 to determine a source pressure generated by thereduced pressure source 108. The sensor may communicate with aprocessing unit that monitors and controls the reduced pressure that isdelivered by the reduced pressure source 108.

The reduced pressure dressing 110 includes a distribution manifold 130adapted to be positioned at the tissue site 101, and a drape 132 thatcovers the distribution manifold 130 to maintain reduced pressurebeneath the drape 132 at the tissue site 101. The drape 132 includes anaperture 134 through which the tubing adapter 114 extends to providefluid communication between the conduit 112 and the distributionmanifold 130. The drape 132 further includes a periphery portion 136that may extend beyond a perimeter of the tissue site 101 and mayinclude an adhesive or bonding agent (not shown) to secure the drape 132to tissue adjacent the tissue site 101. In one embodiment, the adhesivedisposed on the drape 132 may be used to provide a seal between theepidermis 103 and the drape 132 to prevent leakage of reduced pressurefrom the tissue site 101. In another embodiment, a seal layer (notshown) such as, for example, a hydrogel or other material may bedisposed between the drape 132 and the epidermis 103 to augment orsubstitute for the sealing properties of the adhesive.

The distribution manifold 130 of the reduced pressure dressing 110 isadapted to contact the tissue site 101. The distribution manifold 130may be partially or fully in contact with the tissue site 101 beingtreated by the reduced pressure dressing 110. When the distributionmanifold 130 is in contact with the wound 102 at the tissue site 101,the distribution manifold 130 may partially or fully fill the wound 102.The distribution manifold 130 may be any size, shape, or thicknessdepending on a variety of factors, such as the type of treatment beingimplemented or the nature and size of the tissue site 101 or the wound102. For example, the size and shape of the distribution manifold 130may be customized by a user to cover a particular portion of the tissuesite 101, or to fill or partially fill the tissue site 101 or the wound102. The distribution manifold 130 may have, for example, a squareshape, or may be shaped as a circle, oval, polygon, an irregular shape,or any other shape. The distribution manifold 130 may further promotegranulation at the tissue site 101 when a reduced pressure is appliedthrough the reduced pressure dressing 110. For example, any or all ofthe surfaces of the distribution manifold 130 may have an uneven,coarse, or jagged profile that causes microstrains and stresses at thetissue site 101 when reduced pressure is applied through thedistribution manifold 130. These microstrains and stresses have beenshown to increase new tissue growth.

In one illustrative embodiment, the distribution manifold 130 is a foammaterial that distributes reduced pressure to the tissue site 101 whenthe distribution manifold 130 is in contact with or near the tissue site101. The foam material may be either hydrophobic or hydrophilic. In onenon-limiting example, the distribution manifold 130 is an open-cell,reticulated polyurethane foam such as GranuFoam® dressing available fromKinetic Concepts, Inc. of San Antonio, Tex. In the example in which thedistribution manifold 130 is made from a hydrophilic material, thedistribution manifold 130 also functions to wick fluid away from thetissue site 101, while continuing to provide reduced pressure to thetissue site 101 as a manifold. The wicking properties of thedistribution manifold 130 draw fluid away from the tissue site 101 bycapillary flow or other wicking mechanisms. An example of a hydrophilicfoam is a polyvinyl alcohol, open-cell foam such as V.A.C. WhiteFoam®dressing available from Kinetic Concepts, Inc. of San Antonio, Tex.Other hydrophilic foams may include those made from polyether. Otherfoams that may exhibit hydrophilic characteristics include hydrophobicfoams that have been treated or coated to provide hydrophilicity.

In one embodiment, the distribution manifold 130 may be constructed frombioresorbable materials that do not have to be removed from a patient'sbody following use of the reduced pressure dressing 110. Suitablebioresorbable materials may include, without limitation, a polymericblend of polylactic acid (PLA) and polyglycolic acid (PGA). Thepolymeric blend may also include, without limitation, polycarbonates,polyfumarates, and capralactones. The distribution manifold 130 mayfurther serve as a scaffold for new cell-growth, or a scaffold materialmay be used in conjunction with the distribution manifold 130 to promotecell-growth. A scaffold is a substance or structure used to enhance orpromote the growth of cells or formation of tissue, such as athree-dimensional porous structure that provides a template for cellgrowth. Illustrative examples of scaffold materials include calciumphosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, orprocessed allograft materials.

The drape 132 may be any material that provides a pneumatic or fluidseal. The drape 132 may, for example, be an impermeable orsemi-permeable, elastomeric material.

“Elastomeric” means having the properties of an elastomer, and generallyrefers to a polymeric material that has rubber-like properties. Morespecifically, most elastomers have elongation rates greater than 100%and a significant amount of resilience. The resilience of a materialrefers to the material's ability to recover from an elastic deformation.Examples of elastomers may include, but are not limited to, naturalrubbers, polyisoprene, styrene butadiene rubber, chloroprene rubber,polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber,ethylene propylene diene monomer, chlorosulfonated polyethylene,polysulfide rubber, polyurethane, EVA film, co-polyester, and silicones.Specific examples of drape materials include a silicone drape, 3MTegaderm® drape, acrylic drape such as one available from AveryDennison, or an incise drape.

The reduced pressure dressing 110 further includes a seal 140 that isgenerally annular in shape and disposed between the tissue site 101 andthe drape 132 thereby having a tissue-facing side 142 and a drape-facingside 144 when positioned on the tissue site 101. The drape 132 coversthe seal 140 such that the periphery portion 136 of the drape 132extends beyond the seal 140 so that the adhesive portion of the drape132 adheres to the tissue surrounding the wound 102 at the tissue site101. The seal 140 is substantially solid in form and substantiallysurrounds the wound 102 so that the tissue-facing side 142 is positionedadjacent the epidermis 103 of the tissue site 101. Even though theperiphery portion 136 of the drape 132 functions as an adhesive withsome sealing capability as described above, the epidermis 103 may haverecesses and cracks or other discontinuities on the surface, i.e.,epidermal discontinuities 150, extending beyond the periphery portion136. These epidermal discontinuities 150 form passages 152 through whichair from outside the reduced pressure dressing 110 (“external air”) mayleak into the tissue site 101 when reduced pressure is delivered to thedistribution manifold 130. Additionally, when the drape 132 ispositioned on the tissue site 101, folds or buckles in the drape 132,i.e., drape discontinuities 154, may also form the passages 152 throughwhich external air may leak into the tissue site 101 when reducedpressure is delivered to the distribution manifold 130.

Referring to FIGS. 1 and 3, the seal 140 is initially solid in form thatis made from material adapted to react with fluid such as, for example,the flow of external air as indicated by arrows 155. This reactiontransforms the seal 140 from solid phase to either liquid or gel whichflows or expands to fill the passages 152 created by the epidermaldiscontinuities 150 and/or the drape discontinuities 154. Consequently,the transformed seal 140 forms a sealant 160 that fills the passages 152and prevents the external air from leaking into the tissue site 101 whenreduced pressure is delivered to the distribution manifold 130. Thesealant 160 substantially blocks the passages 152 to prevent theexternal air from being drawn into the wound 102 by the reducedpressure, thereby maintaining the level of reduced pressure beingdelivered by the distribution manifold 130 to the tissue site 101.

The seal 140 may be fabricated from a material containing isocyanatethat reacts with water vapor content of the external air to createcarbon dioxide gas within the material causing the material to expandand fill the passages 152 forming the sealant 160 that plugs thepassages 152 created by the epidermal discontinuities 150 and the drapediscontinuities 154. Water-sensitive polymers may also be used to formthe seal 140. For example, the seal 140 may be formed from anuncrosslinked water-sensitive polymer to liquify when exposed tomoisture. The seal 140 may also be formed from a crosslinkedwater-sensitive polymer to swell when exposed to moisture.Water-sensitive polymers include polyacrylates, polyvinylpyrrolidone,polyvinyl alcohol, alginates, and carboxymethyl cellulose. In anotherexample, the seal 140 may be formed from water-sensitive materials thatliberate gases such as metal hydrides and carbides. Further, hygroscopicmaterials, such as anhydrides, may be used to form the seal 140 some ofwhich may also increase in volume as moisture is absorbed. Thetransformation of a water-sensitive seal 140 to form the sealant 160 maybe initiated or accelerated by first using a sponge or other applicationdevice to wet the surfaces of the seal 140 with water. Furthertransformation results when the water vapor content of the external airreacts with the water-sensitive material being utilized for the seal140.

In another embodiment, the fluid supply 106 may provide the fluid 105 tothe tissue site 101 via the distribution manifold 130 as described aboveand further indicated by arrows 164 wherein the fluid 105 includes anagent that facilitates the transformation of the seal 140 into thesealant 160 when exposed to the leakage of external air that comes incontact with the seal 140. In another embodiment, the fluid supply 106may provide the fluid 105 to the tissue site 101 via the distributionmanifold 130 as described above and further indicated by the arrows 164wherein the fluid 105 includes an agent that causes the transformationof the seal 140 into the sealant 160 without being exposed to theleakage of external air that comes in contact with the seal 140. Forexample, solvents may be introduced as solutions that cause the seal 140to liquefy or swell. As described above, the transformation of awater-sensitive seal 140 to form the sealant 160 may be initiated oraccelerated by first using a sponge or other application device to wetthe surfaces of the seal 140 with either water or the solvent.

Examples of solvents that may be used include alcohols, glycols,polyethylene glycols, and glycerine that react with a seal 140 that isfabricated from materials such as modified polyurethanes, acrylics, andacetates. Other solvents, incompatible with water, may also be used andintroduced as emulsions or dispersions that are absorbed by the seal 140which liquefies or swells as a result of the reaction. Examples of thesewater-incompatible solvents include esters, phthalates, trimellitates,citrates, and vegetable oils. The seal 140 may also be formed frompolyurethane that contains an active substance that expands upon contactwith the fluid 105. The polyurethane may also function as an adhesive sothat the sealant 160 adheres more tightly to the drape 132 and thepatient's epidermis 103.

In another embodiment, the seal 140 may also include isocyanate,tartaric acid and sodium bicarbonate, super absorbent fiber that expandswhen exposed to a fluid, or water-absorbing polymers that swell whenexposed to a fluid. In the example in which the seal 140 is formed froma fiber, the fiber may form a mesh such that the fibers are orientedalong at least two directions and intersect with one another. In oneembodiment, the expansion of the seal 140 may be caused by the formationof bubbles within the seal 140 after it transforms into the sealant 160.These bubbles may be caused by the release of carbon dioxide uponcontact between the seal 140 and the fluid 105. The specific materialused for the seal 140 may depend upon the manner in which the expansionof the seal 140 is activated. Also, the shape of the seal 140 can varydepending on the manner in which the seal 140 is used or applied.

The expansion of the seal 140 can be activated using any of a variety ofmechanisms depending on the embodiment employed, and severalnon-limiting examples follow. In one example, as discussed above, theseal 140 expands in the presence of the fluid 105 delivered from thefluid supply 106 via the distribution manifold 130 as indicated by thearrows 164 in FIG. 3. The fluid 105 flows through the distributionmanifold 130 and contacts the seal 140 causing it to expand to fill thepassages 152 created by the epidermal discontinuities 150 and the drapediscontinuities 154 as described above. The fluid 105 may continue to besupplied to the sealant 160 after the expansion of the seal 140 toprovide therapy to the wound 102.

The fluid used to activate and expand the seal 140 may originate fromsources other than the fluid supply 106. In one embodiment, the fluidsupplied to the seal 140 may be exudate from the wound 102. In thisexample, the exudate flows to the seal 140 as indicated by exudate flowarrows 157. In another example, fluid may be supplied to the seal 140 bypre-applying the fluid to the tissue site 101 with a sponge or otherapplication device and, more specifically, the surface layer of theepidermis 103, before applying the reduced pressure dressing 110 to thetissue site 101. This pre-applied fluid may be a gel or liquidsufficient to activate the expansion of the seal 140. In yet anotherexample, a fluid may be applied to the seal 140 from under the peripheryportion 136 of the drape 132 after the reduced pressure dressing 110 hasbeen applied to the tissue site 101. In this example the fluid may besprayed, injected, or otherwise applied onto or into the seal 140 by acare giver, including the patient. Although the care giver may desire toexpose all or a substantial portion of the seal 140 to the fluid, thecare giver may also apply the fluid to targeted regions of the seal 140based on an assessment of the areas in the reduced pressure dressing 110where the passages 152 are detected. Using this technique, a care givermay determine the areas at which a fluid lead exists in the reducedpressure dressing 110, and apply the fluid to those portions of the seal140 that are adjacent the passages 152.

In another example of a mechanism by which the seal 140 may be exposedto a fluid, reduced pressure may be applied to the distribution manifold130 so that the external air is drawn to the seal 140 from the outsideof the reduced pressure dressing 110 through the passages 152 asdescribed above and as indicated by the arrows 155. When contacting theseal 140, the vapor or humidity within the air reacts with the seal 140as described above. The seal 140 may be formed from material that reactswith the air or component thereof. For example, the seal 140 may reactwith oxygen, carbon dioxide, or other component of the gas to cause theexpansion of the seal 140. In another embodiment, the seal 140 may beformed from material that reacts to gases other than air that may beexternally injected into the passages 152 causing the seal 140 toexpand. Examples of materials that increase in volume when absorbing agas include iron that reacts with oxygen to form iron oxide (Fe₂O₃), andzinc oxide that reacts with carbon dioxide to form zinc carbonate.Amines and alcohol amines may also be used in the seal 140 to absorbcarbon dioxide.

In yet another example, reduced pressure can be applied to thedistribution manifold 130 to create a pressure differential under thedrape 132 of sufficient magnitude to cause the expansion of the seal140. In this example, the seal 140 is formed from a material thatexpands when a pressure drop exists across the length of the material.In one embodiment, the seal 140 may be a composition comprising amaterial containing polymer spheres or bubbles (e.g., Expancel® fromAkzo Nobel N.V. located at Strawinskylaan 2555, 1077 ZZ Amsterdam,Postbus 75730) that are filled with low boiling point liquids. Uponheating, the polymer softens and the spheres expand so that the seal 140fills any of the passages 152. Alternatively, the polymer spheres maysoften into an elastic state without a significant change in theinternal pressure or the corresponding size of the spheres. When areduced pressure is applied to the seal 140, however, the elasticspheres are subjected to a pressure differential causing them to expandso that the seal 140 fills the passages 152. The pressure differentialmay be increased further causing the spheres to expand and ultimatelyrupture releasing their contents, such as gels or adhesives, to fill anyof the passages 152 and bind the spheres together to form a tighterseal. Also, the exposed contents may be oxygen sensitive and harden overa period of time to increase the stability of the seal.

The seal 140 and the drape 132 may be applied to the tissue site 101 asa unit, or a care giver can cover the seal 140 with the drape 132 afterthe seal 140 has been applied. In another embodiment, the care giver mayinsert all or a portion of the seal 140 under the periphery portion 136of the drape 132 after the drape 132 has been applied to the tissue site101. By inserting the seal 140 to the reduced pressure dressing 110after the reduced pressure dressing 110 has been applied to the tissuesite 101, the seal 140 may be used in conjunction with existing wounddressings.

Referring now to FIGS. 4 and 5, a reduced pressure dressing 210 is shownthat includes the drape 132, a seal 240 (as shown in FIG. 5) and thedistribution manifold 130. The drape 132 includes a first side 250 and asecond, tissue-facing side 252. The seal 240 is different from the seal140 of FIG. 1 only in shape which covers a substantial portion of thesecond, tissue-facing side 252 of the drape 132. When the seal 240transforms to a gelatinous or liquid state to form a sealant 260 asshown in FIG. 4, the sealant 260 covers a larger surface area of theepidermis 103 to plug more of the passages 152 (not shown) resultingfrom the epidermal discontinuities 150 and drape discontinuities (notshown) as described above. Using a sealant that covers a larger area ofcontact between the drape 132 and the epidermis 103 may further reducethe number and severity of the passages 152 caused by bothdiscontinuities.

A release liner 254 as shown in FIG. 5 may be utilized to cover atissue-facing side 212 of the seal 240, prior to application of thereduced pressure dressing 210 to the tissue site 101. The release liner254 preserves the adhesiveness of the seal 240 prior to the seal's 240contact with the epidermis 103. The release liner 254 also preventsfluid from contacting the seal 240 prior to application of the reducedpressure dressing 210 to the tissue site 101. The release liner 254 maybe formed from any gas or liquid impermeable material to prevent theseal 240 from being contaminated or from transforming to a gelatinous orliquid state before being applied to the tissue site 101. The releaseliner 254 may also have tabs (not shown) so that a care giver can easilypeel the release liner 254 from the seal 240 when desired.

In an alternative embodiment, the seal 240 may be inserted in separatepieces between the drape 132 and the epidermis 103 after the reducedpressure dressing 110 is applied to the tissue site 101. The drape 132may be applied to the tissue site 101 and held in place by an adhesive(not shown) that may also function as a sealant. The peripheral portionof the drape 132 is free from adhesive to leave a space for insertingpieces of the seal 240 between the drape 132 and the epidermis 103 toplug any of the passages 152 that may be detected after reduced pressureis applied to the wound 102. The separate pieces of the seal 240 do notneed to be annular in shape as shown in FIGS. 1 and 4, but rather may bewhatever shape necessary to plug the passages 152 that is detected. Theseparate piece or pieces of seal 240 are inserted under the drape 132 atthe desired location and then exposed to any of the stimuli describedabove, e.g., reduced pressure or fluids, to transform the seal to thesealant 160, 260 as shown in FIGS. 3 and 4, respectively.

Although the present invention and its advantages have been disclosed inthe context of certain illustrative, non-limiting embodiments, it shouldbe understood that various changes, substitutions, permutations, andalterations can be made without departing from the scope of theinvention as defined by the appended claims.

1. A system for treating a wound at a tissue site, the systemcomprising: a pressure source to supply reduced pressure; a manifold influid communication with said pressure source to provide reducedpressure to the wound; a drape adhering to the tissue site to cover thewound and said manifold, there being passages between said drape and thetissue site; and, a seal disposed between said drape and the tissuesite, said seal adapted to react with a fluid to form a sealantsubstantially filling the passages in response to air leaking throughthe passages from outside said drape when said manifold provides reducedpressure to the wound.
 2. The system of claim 1, wherein said sealcontains an isocyanate material and the fluid is water vapor containedin the air that leaks from outside said drape to contact said seal. 3.The system of claim 1, wherein said seal is a water-sensitive polymerand the fluid is water vapor contained in the air that leaks fromoutside said drape to contact said seal.
 4. The system of claim 3,wherein the water-sensitive polymer is polyacrylate,polyvinylpyrrolidone, polyvinyl alcohol, alginates, or carboxymethylcellulose.
 5. The system of claim 1, wherein said seal is awater-sensitive polymer and the fluid is exudates from the wound thatcontact said seal.
 6. The system of claim 1, wherein said seal is awater-sensitive polymer and the fluid is water applied to said seal. 7.The system of claim 1, wherein said seal is a water-sensitive materialthat liberates gases to form the sealant and the fluid is water vaporcontained in the air that leaks from outside said drape to contact saidseal.
 8. The system of claim 7, wherein the water-sensitive material isa metal hydride or a metal carbide.
 9. The system of claim 1, furthercomprising a fluid supply for providing the fluid to the tissue site.10. The system of claim 9, wherein the seal is polyurethane, acrylic, oracetate and the fluid is a solvent.
 11. The system of claim 10, whereinthe solvent is alcohol, glycol, polyethylene glycol, or glycerine. 12.The system of claim 1, wherein the fluid is a gas drawn into saidmanifold in response to application of reduced pressure to the tissuesite, wherein the gas reacts with said seal to expand said seal to formthe sealant.
 13. The system of claim 1, wherein the fluid is pre-appliedto the tissue site.
 14. The system of claim 1, wherein said seal is amaterial comprising polymer spheres responsive to reduced pressure andexpanding in response to a pressure differential provided by saidpressure source to form the sealant.
 15. The system of claim 1, whereinsaid seal has a first side and a second side facing the tissue site,further comprising: a release liner covering at least one of the firstside and the second side of the seal, the release liner adapted toprevent said seal from forming the sealant prior to application of theseal and the drape to the tissue site.
 16. The system of claim 1,wherein said seal expands to form the sealant for filling the passages.17. The system of claim 1, wherein the sealant at least partially fillsthe passages formed by a fold in said drape to substantially seal thepassages.
 18. The system of claim 1, wherein the seal forms an annulusat least partially surrounding the wound at the tissue site.
 19. Thesystem of claim 1, wherein said drape has a first side and a second sidefacing the tissue site, and wherein said seal substantially covers thesecond side of said drape.
 20. The system of claim 1, wherein thesealant is adhesive and operable to cause said drape to adhere to thetissue site.
 21. An apparatus for treating a wound at a tissue site, theapparatus comprising: a manifold adapted to provide reduced pressure tothe wound; a drape having an adhesive surface for adhering to the tissuesite to cover the wound and said manifold, there being passages betweensaid drape and the tissue site; and, a seal adjacent the adhesivesurface of said drape, said seal disposed between said drape and thetissue site when applied to the tissue site and transformable to form asealant substantially filling the passages between said drape and thetissue site when said manifold provides reduced pressure to the wound;whereby air leaks from outside said drape are reduced when said manifoldprovides reduced pressure to the wound.
 22. The apparatus of claim 21,wherein said seal contains an isocyanate material reactive with watervapor and transforms to form the sealant in response to water vaporcontained in air when air leaks from outside said drape and contactssaid seal.
 23. The apparatus of claim 21, wherein said seal is awater-sensitive polymer that transforms to form the sealant in responseto water vapor contained in air when air leaks from outside said drapeand contacts said seal.
 24. The apparatus of claim 23, wherein thewater-sensitive polymer is polyacrylate, polyvinylpyrrolidone, polyvinylalcohol, alginates, or carboxymethyl cellulose. 25-40. (canceled)
 41. Amethod for sealing a drape to a tissue site for treating a wound at thetissue site, the method comprising: applying the drape to cover thetissue site whereby passages are formed between the drape and the tissuesite; positioning a seal between the drape and the tissue site whereinthe seal is adapted to react with a fluid to form a sealant forsubstantially filling the passages; applying reduced pressure to thetissue site; and, applying the fluid to the seal to form the sealant,whereby the sealant substantially fills the passages and reduces airleaking from outside said drape when reduced pressure is applied to thetissue site. 42-50. (canceled)
 51. A method for treating a tissue siteof a patient, the method comprising: applying a dressing to the tissuesite, the dressing comprising: a seal having a first side and a second,tissue-facing side, the seal adapted for placement adjacent the tissuesite, the seal operable to expand in a presence of a fluid to form asubstantially sealed space at the tissue site; and a drape for coveringthe seal and further forming the substantially sealed space. 52-58.(canceled)